N/A
N=157
AVAI: Atrial Ventricular Arrythmia Incidence
Ventricular Tachycardia · Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00832975 ↗Enrolled (actual)
157
Serious AEs
42.7%
Results posted
Mar 2015
Primary outcome: Primary: Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) — 3778; 112; 68; 308 Episodes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) |
3778; 112; 68; 308; 1900; 2864 | — |
| SECONDARY Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure |
5; 31 | — |
Summary
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.
Eligibility Criteria
Inclusion Criteria
- Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)
- Patient has signed the study specific Informed consent document.
- Patient is older than 18 years of age
Exclusion Criteria
- Patient has a permanent Atrial Fibrillation
- Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.
- Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.
- Patient requires cardiac resynchronization
- Patient has Brugada Syndrome
- Patient has long QT Syndrome
- Patient has a device replacement;
- Patient is pregnant or nursing
- Patient is unable to attend the follow-up visits
Data sourced from ClinicalTrials.gov (NCT00832975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.